FDA Approves Higher Dose of Naloxone Nasal Spray for Opioid Overdose
Everyone in the treatment community knows that a higher dose of naloxone nasal spray will save more lives. Thus, the U.S. Food and Drug Administration (FDA) announcement comes with a sigh of relief. To reduce the toll taken nationally by the opioid use disorder (OUI) crisis, the FDA takes a proactive approach.
Hence, the FDAapproves a higher dose of naloxone nasal spray product to counter opioid overdoses. On the front lines of the crisis, Tarzana Treatment Centers, Inc. (TTC) commends this intelligent decision. Indeed, such proactive action is necessary when the national overdose rates continue to climb.
A Higher Dosage of Naloxone Nasal Spray
Previously, 2 milligrams (mg) and 4 mg naloxone nasal spray products had been approved. The new product delivers 8mgof naloxone into the nasal cavity. As a medicine that individuals can administer with or without medical training, Naloxone is a true lifesaver. It helps reduce opioid overdose deaths by countering the deadly effects. When naloxone is administered quickly, it usually brings the overdose victim back to health within minutes.
However, the lower doses often were not enough when it comes to severe cases of opioid overdose. Realizing this fact, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, explains, “Today’s action meets another critical need in combatting opioid overdose. Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”
In the past few years, the main efforts by the FDA have been to improve the availability of naloxone products. Indeed, a major goal is to team with manufacturers to foster the future approval of over-the-counter naloxone products. Moreover,an increase in the durability of naloxone nasal spray products led to greater shelf life. Thus, the viability of the naloxone nasal sprays wentfrom 24 months to 36 months.When the situation involves life and death, this extension is a major step in the direction.
Naloxone Nasal Spray and Opioid-Dependent Patients
With extensive experiencetreating opioid-dependent patients, TTC sees firsthand the challenging effects of naloxone nasal spray once administered. As an opioid antagonist, the active ingredient in the nasal spray binds to opioid receptors. Thus, it reverses and blocks the effects of other opioids.
Given this effect, as an opioid antagonist,the drug often results in immediate opioid withdrawal when administered to opioid-dependent patients.Without any argument, opioid withdrawal is like a bad flu. Although it does not kill the patient, it makes them feel sick with flu-like symptoms. Still, if anyone chooses between being sick from opioid withdrawal or being dead, the choice to make is obvious.
Moving forward, the hope is that all dosage levels of naloxone will be universally accessible and over the counter. After all, naloxone nasal spray saves lives. Is there anything more important?